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A F Cohen - One of the best experts on this subject based on the ideXlab platform.
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a study of the effects of long term use on individual sensitivity to Temazepam and lorazepam in a clinical population
British Journal of Clinical Pharmacology, 2003Co-Authors: Alfred L Van Steveninck, Rik C. Schoemaker, Joop M. A. Van Gerven, Meindert Danhof, M S M Pieters, Andreas E Wallnofer, A F CohenAbstract:Aims The central effects of benzodiazepines may be attenuated after chronic use by changes in pharmacokinetics, pharmacodynamics or both. This attenuation may be influenced by the dosing pattern and the characteristics of the user population. The objectives of this study were to evaluate drug sensitivity in long-term users of Temazepam and lorazepam in a clinical population. Methods The sensitivity to benzodiazepine effects in chronic users (1–20 years) of lorazepam (n=14) or Temazepam (n=13) was evaluated in comparison with age and sex matched controls. Drug sensitivity was evaluated by plasma concentration in relation to saccadic eye movement parameters, postural stability and visual analogue scales. Results Pharmacokinetics of lorazepam and Temazepam did not differ between patients and control subjects. Chronic users of lorazepam showed clear evidence of reduced sensitivity, indicated by lack of any pharmacodynamic difference between patients and controls at baseline, when drug concentrations were similar to the peak values attained in the control subjects after administration of 1–2.5 mg of lorazepam. In addition, there was a two- to four fold reduction in the slopes of concentration-effect plots for measures of saccadic eye movements and body sway (all; P≤0.01). By contrast, sensitivity in chronic users of Temazepam was not different from controls. The difference between the Temazepam and the lorazepam group appears to be associated with a more continuous drug exposure in the latter, due to the longer half-life and a more frequent intake of lorazepam. This pattern of use may be partly related to the more anxious personality traits that were observed in the chronic users of lorazepam. Conclusions Chronic users of lorazepam show evidence of tolerance to sedative effects in comparison with healthy controls. Tolerance does not occur in chronic users of Temazepam. The difference may be related to pharmacological properties, in addition to different patterns of use, associated with psychological factors.
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a pharmacodynamic markov mixed effect model for the effect of Temazepam on sleep
Clinical Pharmacology & Therapeutics, 2000Co-Authors: Mats O. Karlsson, Rik C. Schoemaker, B. Kemp, Joop M. A. Van Gerven, Carl C. Peck, A F Cohen, Meindert DanhofAbstract:Background A hypnogram shows how sleep travels through its various stages in the course of a night. The sleep stage changes can be quantified to study sedative drug effects. Methods Hypnograms from 21 patients with primary insomnia were collected during a randomized, placebo-controlled crossover study of 20 mg Temazepam. A separate daytime session was performed to determine the pharmacokinetics of 20 mg Temazepam and its effect on saccadic eye movement and electroencephalogram. A first-order Markov model was developed to describe the probability of sleep stage changes as a function of time after drug intake and time after last sleep stage change. The influence of Temazepam concentration on the probability to change sleep stage was incorporated into the model. Results Transitions between sleep stages were profoundly influenced by the time of the night and by the time since the last change of sleep stage. Temazepam reduced the time spent awake. This effect could be attributed to four mechanisms: (1) transition to “deeper” sleep was facilitated, (2) transition to “lighter” sleep was inhibited, (3) regardless of sleep stage, the transition to wake state was inhibited, and (4) return to sleep was facilitated. Daytime sensitivities to Temazepam, measured with the surrogate markers saccadic peak velocity and electroencephalogram beta activity, each correlated with one of the transition probabilities influenced by Temazepam. Conclusions By the development of a Markov model for these non-ordered six categorical data, the effect of Temazepam on the sleep-wake status could be interpreted in terms of known mechanisms for sleep generation and benzodiazepine pharmacology. Clinical Pharmacology & Therapeutics (2000) 68, 175–188; doi: 10.1067/mcp.2000.108669
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effects of intravenous Temazepam i saccadic eye movements and electroencephalogram after fast and slow infusion to pseudo steady state
Clinical Pharmacology & Therapeutics, 1994Co-Authors: Alfred L Van Steveninck, H C Schoemaker, Jan Den Hartigh, Jolanda M Rijnkels, M S M Pieters, D D Breimer, A F CohenAbstract:Objective To study the pharmacodynamic effects of intravenous Temazepam after different infusion rates to pseudo steady-state concentrations. Methods This was a randomized, double-blind, placebo-controlled crossover study in an academic department of clinical pharmacology. Subjects were nine healthy volunteers. A computerized infusion pump was used to obtain target plasma concentrations of Temazepam after 30 or 120 minutes and to maintain these levels for 2 hours. A vehicle inftision, similar to the 30-minute (fast) infusion was used as a placebo control. Infusion schedules were based on data obtained from individual subjects after inftision of 0.4 mg/kg Temazepam in 30 minutes. Target plasma concentrations were chosen to induce subhypnotic effects and averaged (± SD) 597 ± 123 ng/ml. Venous plasma concentrations of Temazepam were measured by HPLC. Free fractions of Temazepam were assessed at the start of the pseudo steady-state concentration intervals. Electroencephalogram alpha and beta amplitudes, saccadic peak velocity, and saccadic latency were used as pharmacodynamic parameters. Results The rate of change of plasma concentrations averaged 21 ± 4 ng/ml · min−1 during fast infusion and 5 ± 1 ng/ml · min−1 during slow infusion of Temazepam. Average pseudo steady-state concentrations were 639 ± 132 ng/ml after fast infusion and 629 ± 133 ng/ml after slow infusion. At the onset of pseudo steady-state concentration intervals the average free fractions of Temazepam were 44% (95% confidence interval, 19% to 61%) lower for slow than for fast infusions. Compared with the slow infusion, electroencephalogram beta amplitudes were significantly larger during the first 30 minutes of pseudo steady-state concentration after fast infusion of Temazepam. No significant differences were found for the other parameters. There was a slight decline of Temazepam effects during the pseudo steady-state concentration intervals for all parameters after the fast infusion and for saccadic peak velocity and saccadic latency after the slow infusion. Conclusions The pharmacodynamic effects of intravenous Temazepam may depend partly on the rate of administration. Differences in pharmacodynamic effects after fast and slow infusions could be caused by changes in protein binding over time. Clinical Pharmacology and Therapeutics (1994) 55, 535–545; doi:10.1038/clpt.1994.67
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effects of Temazepam on saccadic eye movements concentration effect relationships in individual volunteers
Clinical Pharmacology & Therapeutics, 1992Co-Authors: Alfred L Van Steveninck, H C Schoemaker, M S M Pieters, D D Breimer, Susanne Verver, Ria Kroon, A F CohenAbstract:: Saccadic eye movements were analyzed after single oral doses of 20 mg Temazepam and placebo in a randomized, double-blind crossover study in eight healthy volunteers. For an optimal evaluation of concentration-effect relationships, 18 blood samples and 43 effect measures were obtained over 33 1/2 hours. After placebo, saccadic peak velocity decreased within the first hour, with average values remaining 6.2% to 12.1% below baseline up to 15 hours after intake. After Temazepam, significant changes in peak velocity occurred for 5 hours, with maximum decreases averaging 29.2% (95% confidence interval, 10.0 to 37.2). The apparent duration of effects ranged from 3 to 9 hours in individual subjects. Linear concentration-effect relationships were demonstrated for peak velocity, with individual slopes ranging from -0.11 to -0.46 deg/sec.(ng/ml)-1 (average r = -0.82, all p < 0.01). Differences in protein binding of Temazepam did not account for the approximate fourfold variability in individual sensitivities to Temazepam. By increasing the frequency of measurements, the accuracy of pharmacodynamic evaluations was clearly enhanced in this study.
Alfred L Van Steveninck - One of the best experts on this subject based on the ideXlab platform.
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a study of the effects of long term use on individual sensitivity to Temazepam and lorazepam in a clinical population
British Journal of Clinical Pharmacology, 2003Co-Authors: Alfred L Van Steveninck, Rik C. Schoemaker, Joop M. A. Van Gerven, Meindert Danhof, M S M Pieters, Andreas E Wallnofer, A F CohenAbstract:Aims The central effects of benzodiazepines may be attenuated after chronic use by changes in pharmacokinetics, pharmacodynamics or both. This attenuation may be influenced by the dosing pattern and the characteristics of the user population. The objectives of this study were to evaluate drug sensitivity in long-term users of Temazepam and lorazepam in a clinical population. Methods The sensitivity to benzodiazepine effects in chronic users (1–20 years) of lorazepam (n=14) or Temazepam (n=13) was evaluated in comparison with age and sex matched controls. Drug sensitivity was evaluated by plasma concentration in relation to saccadic eye movement parameters, postural stability and visual analogue scales. Results Pharmacokinetics of lorazepam and Temazepam did not differ between patients and control subjects. Chronic users of lorazepam showed clear evidence of reduced sensitivity, indicated by lack of any pharmacodynamic difference between patients and controls at baseline, when drug concentrations were similar to the peak values attained in the control subjects after administration of 1–2.5 mg of lorazepam. In addition, there was a two- to four fold reduction in the slopes of concentration-effect plots for measures of saccadic eye movements and body sway (all; P≤0.01). By contrast, sensitivity in chronic users of Temazepam was not different from controls. The difference between the Temazepam and the lorazepam group appears to be associated with a more continuous drug exposure in the latter, due to the longer half-life and a more frequent intake of lorazepam. This pattern of use may be partly related to the more anxious personality traits that were observed in the chronic users of lorazepam. Conclusions Chronic users of lorazepam show evidence of tolerance to sedative effects in comparison with healthy controls. Tolerance does not occur in chronic users of Temazepam. The difference may be related to pharmacological properties, in addition to different patterns of use, associated with psychological factors.
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effects of intravenous Temazepam i saccadic eye movements and electroencephalogram after fast and slow infusion to pseudo steady state
Clinical Pharmacology & Therapeutics, 1994Co-Authors: Alfred L Van Steveninck, H C Schoemaker, Jan Den Hartigh, Jolanda M Rijnkels, M S M Pieters, D D Breimer, A F CohenAbstract:Objective To study the pharmacodynamic effects of intravenous Temazepam after different infusion rates to pseudo steady-state concentrations. Methods This was a randomized, double-blind, placebo-controlled crossover study in an academic department of clinical pharmacology. Subjects were nine healthy volunteers. A computerized infusion pump was used to obtain target plasma concentrations of Temazepam after 30 or 120 minutes and to maintain these levels for 2 hours. A vehicle inftision, similar to the 30-minute (fast) infusion was used as a placebo control. Infusion schedules were based on data obtained from individual subjects after inftision of 0.4 mg/kg Temazepam in 30 minutes. Target plasma concentrations were chosen to induce subhypnotic effects and averaged (± SD) 597 ± 123 ng/ml. Venous plasma concentrations of Temazepam were measured by HPLC. Free fractions of Temazepam were assessed at the start of the pseudo steady-state concentration intervals. Electroencephalogram alpha and beta amplitudes, saccadic peak velocity, and saccadic latency were used as pharmacodynamic parameters. Results The rate of change of plasma concentrations averaged 21 ± 4 ng/ml · min−1 during fast infusion and 5 ± 1 ng/ml · min−1 during slow infusion of Temazepam. Average pseudo steady-state concentrations were 639 ± 132 ng/ml after fast infusion and 629 ± 133 ng/ml after slow infusion. At the onset of pseudo steady-state concentration intervals the average free fractions of Temazepam were 44% (95% confidence interval, 19% to 61%) lower for slow than for fast infusions. Compared with the slow infusion, electroencephalogram beta amplitudes were significantly larger during the first 30 minutes of pseudo steady-state concentration after fast infusion of Temazepam. No significant differences were found for the other parameters. There was a slight decline of Temazepam effects during the pseudo steady-state concentration intervals for all parameters after the fast infusion and for saccadic peak velocity and saccadic latency after the slow infusion. Conclusions The pharmacodynamic effects of intravenous Temazepam may depend partly on the rate of administration. Differences in pharmacodynamic effects after fast and slow infusions could be caused by changes in protein binding over time. Clinical Pharmacology and Therapeutics (1994) 55, 535–545; doi:10.1038/clpt.1994.67
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effects of Temazepam on saccadic eye movements concentration effect relationships in individual volunteers
Clinical Pharmacology & Therapeutics, 1992Co-Authors: Alfred L Van Steveninck, H C Schoemaker, M S M Pieters, D D Breimer, Susanne Verver, Ria Kroon, A F CohenAbstract:: Saccadic eye movements were analyzed after single oral doses of 20 mg Temazepam and placebo in a randomized, double-blind crossover study in eight healthy volunteers. For an optimal evaluation of concentration-effect relationships, 18 blood samples and 43 effect measures were obtained over 33 1/2 hours. After placebo, saccadic peak velocity decreased within the first hour, with average values remaining 6.2% to 12.1% below baseline up to 15 hours after intake. After Temazepam, significant changes in peak velocity occurred for 5 hours, with maximum decreases averaging 29.2% (95% confidence interval, 10.0 to 37.2). The apparent duration of effects ranged from 3 to 9 hours in individual subjects. Linear concentration-effect relationships were demonstrated for peak velocity, with individual slopes ranging from -0.11 to -0.46 deg/sec.(ng/ml)-1 (average r = -0.82, all p < 0.01). Differences in protein binding of Temazepam did not account for the approximate fourfold variability in individual sensitivities to Temazepam. By increasing the frequency of measurements, the accuracy of pharmacodynamic evaluations was clearly enhanced in this study.
M S M Pieters - One of the best experts on this subject based on the ideXlab platform.
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a study of the effects of long term use on individual sensitivity to Temazepam and lorazepam in a clinical population
British Journal of Clinical Pharmacology, 2003Co-Authors: Alfred L Van Steveninck, Rik C. Schoemaker, Joop M. A. Van Gerven, Meindert Danhof, M S M Pieters, Andreas E Wallnofer, A F CohenAbstract:Aims The central effects of benzodiazepines may be attenuated after chronic use by changes in pharmacokinetics, pharmacodynamics or both. This attenuation may be influenced by the dosing pattern and the characteristics of the user population. The objectives of this study were to evaluate drug sensitivity in long-term users of Temazepam and lorazepam in a clinical population. Methods The sensitivity to benzodiazepine effects in chronic users (1–20 years) of lorazepam (n=14) or Temazepam (n=13) was evaluated in comparison with age and sex matched controls. Drug sensitivity was evaluated by plasma concentration in relation to saccadic eye movement parameters, postural stability and visual analogue scales. Results Pharmacokinetics of lorazepam and Temazepam did not differ between patients and control subjects. Chronic users of lorazepam showed clear evidence of reduced sensitivity, indicated by lack of any pharmacodynamic difference between patients and controls at baseline, when drug concentrations were similar to the peak values attained in the control subjects after administration of 1–2.5 mg of lorazepam. In addition, there was a two- to four fold reduction in the slopes of concentration-effect plots for measures of saccadic eye movements and body sway (all; P≤0.01). By contrast, sensitivity in chronic users of Temazepam was not different from controls. The difference between the Temazepam and the lorazepam group appears to be associated with a more continuous drug exposure in the latter, due to the longer half-life and a more frequent intake of lorazepam. This pattern of use may be partly related to the more anxious personality traits that were observed in the chronic users of lorazepam. Conclusions Chronic users of lorazepam show evidence of tolerance to sedative effects in comparison with healthy controls. Tolerance does not occur in chronic users of Temazepam. The difference may be related to pharmacological properties, in addition to different patterns of use, associated with psychological factors.
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effects of intravenous Temazepam i saccadic eye movements and electroencephalogram after fast and slow infusion to pseudo steady state
Clinical Pharmacology & Therapeutics, 1994Co-Authors: Alfred L Van Steveninck, H C Schoemaker, Jan Den Hartigh, Jolanda M Rijnkels, M S M Pieters, D D Breimer, A F CohenAbstract:Objective To study the pharmacodynamic effects of intravenous Temazepam after different infusion rates to pseudo steady-state concentrations. Methods This was a randomized, double-blind, placebo-controlled crossover study in an academic department of clinical pharmacology. Subjects were nine healthy volunteers. A computerized infusion pump was used to obtain target plasma concentrations of Temazepam after 30 or 120 minutes and to maintain these levels for 2 hours. A vehicle inftision, similar to the 30-minute (fast) infusion was used as a placebo control. Infusion schedules were based on data obtained from individual subjects after inftision of 0.4 mg/kg Temazepam in 30 minutes. Target plasma concentrations were chosen to induce subhypnotic effects and averaged (± SD) 597 ± 123 ng/ml. Venous plasma concentrations of Temazepam were measured by HPLC. Free fractions of Temazepam were assessed at the start of the pseudo steady-state concentration intervals. Electroencephalogram alpha and beta amplitudes, saccadic peak velocity, and saccadic latency were used as pharmacodynamic parameters. Results The rate of change of plasma concentrations averaged 21 ± 4 ng/ml · min−1 during fast infusion and 5 ± 1 ng/ml · min−1 during slow infusion of Temazepam. Average pseudo steady-state concentrations were 639 ± 132 ng/ml after fast infusion and 629 ± 133 ng/ml after slow infusion. At the onset of pseudo steady-state concentration intervals the average free fractions of Temazepam were 44% (95% confidence interval, 19% to 61%) lower for slow than for fast infusions. Compared with the slow infusion, electroencephalogram beta amplitudes were significantly larger during the first 30 minutes of pseudo steady-state concentration after fast infusion of Temazepam. No significant differences were found for the other parameters. There was a slight decline of Temazepam effects during the pseudo steady-state concentration intervals for all parameters after the fast infusion and for saccadic peak velocity and saccadic latency after the slow infusion. Conclusions The pharmacodynamic effects of intravenous Temazepam may depend partly on the rate of administration. Differences in pharmacodynamic effects after fast and slow infusions could be caused by changes in protein binding over time. Clinical Pharmacology and Therapeutics (1994) 55, 535–545; doi:10.1038/clpt.1994.67
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effects of Temazepam on saccadic eye movements concentration effect relationships in individual volunteers
Clinical Pharmacology & Therapeutics, 1992Co-Authors: Alfred L Van Steveninck, H C Schoemaker, M S M Pieters, D D Breimer, Susanne Verver, Ria Kroon, A F CohenAbstract:: Saccadic eye movements were analyzed after single oral doses of 20 mg Temazepam and placebo in a randomized, double-blind crossover study in eight healthy volunteers. For an optimal evaluation of concentration-effect relationships, 18 blood samples and 43 effect measures were obtained over 33 1/2 hours. After placebo, saccadic peak velocity decreased within the first hour, with average values remaining 6.2% to 12.1% below baseline up to 15 hours after intake. After Temazepam, significant changes in peak velocity occurred for 5 hours, with maximum decreases averaging 29.2% (95% confidence interval, 10.0 to 37.2). The apparent duration of effects ranged from 3 to 9 hours in individual subjects. Linear concentration-effect relationships were demonstrated for peak velocity, with individual slopes ranging from -0.11 to -0.46 deg/sec.(ng/ml)-1 (average r = -0.82, all p < 0.01). Differences in protein binding of Temazepam did not account for the approximate fourfold variability in individual sensitivities to Temazepam. By increasing the frequency of measurements, the accuracy of pharmacodynamic evaluations was clearly enhanced in this study.
Craig R. Rush - One of the best experts on this subject based on the ideXlab platform.
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acute performance impairing and subject rated effects of triazolam and Temazepam alone and in combination with ethanol in humans
Journal of Psychopharmacology, 2002Co-Authors: Cathy A Simpson, Craig R. RushAbstract:The acute behavioural effects of triazolam (0.125 and 0.25 mg), Temazepam (15 and 30 mg), and placebo, alone and in combination with ethanol (0 and 0.5 g/kg), were assessed in 10 volunteers. Ethanol alone did not impair performance and produced only a few subject-rated drug effects. Triazolam and Temazepam alone produced some performance impairment and a few subject-rated drug effects. These effects tended to be dose-dependent and were comparable for the two drugs across the range of doses tested. The triazolam-ethanol and Temazepam-ethanol combinations produced robust performance impairment and sedative-like subject-rated drug effects that were similar in magnitude. The findings of the present study suggest that even a moderate amount of ethanol in combination with a clinical dose of triazolam or Temazepam can cause performance impairment that might diminish an individual's ability to respond adequately to unexpected demands (e.g. smoke alarms or middle-of-the-night child care).
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zolpidem triazolam and Temazepam behavioral and subject rated effects in normal volunteers
Journal of Clinical Psychopharmacology, 1996Co-Authors: Craig R. Rush, Roland R GriffithsAbstract:Zolpidem is an imidazopyridine hypnotic that is biochemically distinct from classic benzodiazepine agonists in that it may be selective for the BZ1 receptor subtype and shows a different pattern of distribution of binding sites.The present study compared the learning, recall, performance, subject-rated and observer-rated effects of zolpidem, triazolam, and Temazepam in 11 healthy humans. Placebo, zolpidem (5, 10, and 20 mg/70 kg), triazolam (0.125, 0.25, and 0.50 mg/70 kg), and Temazepam (15, 30, and 60 mg/70 kg) were administered orally in a randomized, double-blind, crossover design. Zolpidem, triazolam, and Temazepam produced orderly dose- and time-related impairment of learning, recall, and performance, and increased subject- and observer-rated estimates of strength of drug effect. The absolute magnitude of these effects at peak effect were comparable across the three compounds. The time to maximal drug effect was faster with zolpidem (0.5-1.0 hours) than with triazolam (1.5-2.0 hours) or Temazepam (2-3 hours). These results suggest that despite the somewhat unique benzodiazepine receptor-binding profile of zolpidem, its behavioral and subject-rated effects are similar to those of benzodiazepine hypnotics (i.e., triazolam and Temazepam). (J Clin Psychopharmacol 1996:16:146-157).
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A comparison of the acute behavioral effects of triazolam and Temazepam in normal volunteers.
Psychopharmacology, 1993Co-Authors: Craig R. Rush, Stephen T. Higgins, John R. Hughes, Warren K. BickelAbstract:Two experiments were conducted to assess the acute behavioral effects of triazolam and Temazepam in healthy, non-drug abusing men in double-blind, placebocontrolled, crossover trials, where all subjects received all possible doses. These drugs were compared to examine allegations that triazolam produces greater behavioral impairment than Temazepam. Drug effect were assessed during 4-h sessions using measures of recall, learning, psychomotor performance, and subject ratings assessing drug effects and abuse potential. In experiment 1, triazolam (0.25 and 0.5 mg/70 kg) produced greater behavioral impairment than Temazepam (15 and 30 mg/70 kg). However, triazolam also produced greater increases than Temazepam in subject ratings of drug strength, drunkenness and sleepiness, suggesting the dose ranges compared may not have been clinically equivalent. Experiment 2 was conducted to assess whether a higher dose of Temazepam than tested in experiment 1 would produce levels of behavioral impairment comparable to those observed with triazolam in experiment 1. In experiment 2, the Temazepam dose was increased to 60 mg/70 kg while the triazolam dose was 0.5 mg/70 kg which was the highest dose tested in experiment 1. These doses produced comparable increases in subject ratings of drug strength, drunkenness and sleepiness, but Temazepam produced significantly more behavioral disruption than triazolam. These findingsdo not support the position that triazolam produces greater behavioral impairment than Temazepam, and may even suggest that across a wide range of doses triazolam isless disruptive than Temazepam.
Martin B. Scharf - One of the best experts on this subject based on the ideXlab platform.
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Effects of Temazepam 7.5 mg and Temazepam 15 mg on sleep maintenance and sleep architecture in a model of transient insomnia.
Current Medical Research and Opinion, 2005Co-Authors: Milton K. Erman, Derek B Loewy, Martin B. ScharfAbstract:Objective To compare the effects of Temazepam 7.5 mg and Temazepam 15 mg on sleep maintenance during the last third of the night (last 160 min) and on sleep architecture throughout the night. Research design and methods This was a retrospective analysis of a previously reported double-blind, randomized, uncontrolled, parallel-group, multicenter study. Healthy subjects with previous but no current complaints of transient insomnia were enrolled. Transient insomnia was induced in the sleep laboratory by means of the 'first night' effect and by implementing a 2-h phase advance. The effects of both doses of Temazepam on polysomnographic measures of sleep were evaluated for 1 night. The primary, prospectively-defined analysis of this study showed that 7.5-mg and 15-mg doses of Temazepam had equivalent effects on latency to persistent sleep, total sleep time, and the number of sleep interruptions recorded over an 8-h period. Both doses were well tolerated. The post hoc analysis reported here compared these 2 doses for their effects on sleep maintenance and architecture. Sleep efficiency during the last third of the night was designated as the primary endpoint. The methodology for this analysis was fully defined and documented prior to re-analysis of the database for these parameters. Results Sixty-five subjects received Temazepam 7.5 mg and 66 received Temazepam 15 mg. No statistically significant differences between doses were detected for sleep efficiency or number of sleep interruptions during the last third of the night. Sleep architecture (measured over 8 h) did not differ significantly between groups. Conclusions The 7.5-mg and 15-mg doses of Temazepam were equally effective for maintaining sleep during the last third of the night. Continuity of sleep throughout the night, as reflected by sleep architecture, was also similar regardless of dose. In keeping with current practice guidelines, initiation of treatment with Temazepam for transient insomnia should begin with the 7.5 mg dose.
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comparative efficacy of zolpidem and Temazepam in transient insomnia
Human Psychopharmacology-clinical and Experimental, 2001Co-Authors: Milton K. Erman, C W Erwin, Francis M Gengo, Andrew O Jamieson, Helio Lemmi, Mark W Mahowald, Quentin R Regestein, Thomas Roth, Barbara Rothschechter, Martin B. ScharfAbstract:: This study compared hypnotic effects of zolpidem 10 mg, Temazepam 15 mg and placebo in healthy adults. Two factors expected to promote insomnia, the 'first night effect' and a 2-hour phase advance, were combined in a single night laboratory-based double-blinded protocol. This was a multi-center study, with data collected in 13 sleep laboratories. Subjects with normal sleep histories and without prior sleep laboratory experience were randomly assigned to treatment groups. Medications were administered 15 min before lights out, with polysomnographic monitoring for 7.5 h. Subjective questionnaires and performance tests, digit symbol substitution test (DSST) and symbol copying test (SCT), were administered at study entry and after arising. 630 subjects completed the study and provided data analyzed using repeated measures ANOVAs. Neither agent significantly reduced objective sleep latency relative to placebo. Zolpidem reduced awakenings and wake after sleep onset (WASO); Temazepam did not. Both agents improved sleep efficiency and most subjective sleep measures relative to placebo, with zolpidem superior for five of six subjective outcome measures compared to Temazepam. SCT, morning sleepiness and morning concentration were not altered by any treatment. Zolpidem significantly reduced morning DSST performance; Temazepam did not. Zolpidem 10 mg provided greater subjective hypnotic efficacy than Temazepam 15 mg in this model of transient insomnia, with reduced polysomnographic awakenings and WASO. Impairment of DSST was seen with zolpidem but not Temazepam. Copyright 2001 John Wiley & Sons, Ltd.
